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This section contains various best practices, regulatory know how, articles by experts, user Q&A and other useful content related to regulated industry and roles.

Many personnel in the medical device and pharmaceutical industries are confused about the regulatory requirement for validation of Commercial-Off-the-Shelf (COTS) software. Why is validation required? What systems are considered as quality systems? What do the auditors like to see in the quality system validation? This article discusses the answers. more ....
All FDA regulated products are electronically screened before they enter the U.S. If it appears that the product violates the U.S laws, FDA may refuse entry. FDA's screening program, PREDICT, and U.S. Custom's ACE program requires greater attention to details. Filing incorrect entry data in ACE can attract penalties and greater scrutiny for data verification more ....
Knowledge is power. By understanding the underlying reasons for delay and detention of FDA import products, you can be well-prepared to cut-short or overcome such. Before FDA regulated products enter the U.S, they are electronically screened to ensure that they meet the U.S standards. PREDICT is the software program used in the screening process. If the electronic information you entered more ....
Many Companies continue to struggle with basic data integrity problems. This is evident from the number of warning letters and Form 483 inspectional observations at manufacturing sites around the world. Non-compliance can lead to product seizures, product non-approvals or delays of approvals, import restrictions, substantial fines, disbarment, and criminal liability for individuals or company more ....
Data Integrity has become one of the hot topics during audits and inspections in the pharmaceutical industry. Why has this topic received so much attention? For two vital reasons: The pharmaceutical industry and regulatory agencies need accurate and reliable data to ensure safety, efficacy and quality of a product, It benefits the organization's business continuity decision making process. more ....
To ensure safety and efficacy, Pharmaceutical products must meet the defined quality characteristics throughout its life-cycle. The accountability for the product's quality until its final use rests on the pharmaceutical manufacturer. This article discusses The complexities in the storage and distribution of pharmaceutical products, Obligations of manufacturers in supporting more ....
Pharmaceutical products that are "temperature sensitive" require to be stored within the designated temperature range to ensure that product quality, safety, efficacy, and stability is maintained. Throughout its life-cycle from the manufacturing site, during transit, at warehouse, clinic or a retail outlet, it is the manufacture's responsibility to ensure that the patient receives it in safe, effective more ....
In the modern world, with the rapid growth in technology, companies have turned to computer systems to become more productive. Like most other industries, the FDA regulated firms have also swiftly adapted the use of computer systems to increase the efficiency of individuals, reduce errors, and increase overall productivity. So it is only normal to use electronic records instead of paper records more ....
The regulated industry has developed requirements and standards for managing systems and processes related to product design, development, manufacturing, packaging, distribution, and monitoring. Software vendors design and develop systems to ensure they meet the industry standards. The commercial-off-the-shelf (COTS) software developed and supplied by software vendors more ....
Latin America is a large market with considerable potential for pharmaceutical investment and growth. "The Healthcare landscape in Latin America is changing quickly. Demand is growing as populations age and chronic diseases become commonplace. Increasing wealth in some demographic segments drives a desire for higher quality services. Governments are increasing spending more ....
You receive a written notice from the FDA stating that your facility will be inspected. Shortly thereafter, an FDA investigator arrives at your door for inspection. Are you ready? Whenever FDA sends a written notice for inspection and presents credentials, the Regulated Company should cooperate with FDA in a timely manner. Refusals, denials, or limiting of inspection, or refusal to permit entry more ....
The medical device markets in Latin America (LA) is estimated to be worth $ 11 billion and is rapidly growing. How can a medical device company gain fast access to the LA markets? What are the market entry channels, processes, and typical models? This article explains more ....
The FDA inspects regulated companies to determine if they are in compliance with applicable laws and regulations such as Food, Drug and Cosmetic Act and related Acts. Many professionals who are involved facing the FDA inspections are concerned before, during and after inspections. This is because of a lack of proper know-how, non-compliance with CGMPs, incomplete documentation more ....
Pharmaceutical and biopharmaceutical therapeutics must be sterile and safe for human use. Sterility testing is performed to ensure that the Pharmaceutical and biopharmaceutical therapeutics are actually safe. The testing method to be used for sterility testing is recommended in USP<71>. This article points out to the regulations guiding manufactured product sterility testing more ....
The regulatory bodies have specific verification and validation requirements for manufacturing and quality systems. However, there is not much understanding of the actual requirements and the best practices for meeting the requirements in the industry. The concerned personnel must understand how to meet the V& V requirements and draft a software verification and validation report more ....
Are you a senior manager responsible for process improvements in your organization? If so, developing a process that minimizes human errors is a crucial part of your job. The experience of many companies demonstrates that human error is a key contributor to operating inefficiencies and significant business losses. However, they are often more ....
'To err is human.' Many business leaders with loads of experience acknowledge that human error is a major cause of quality and production losses. Although errors cannot be fully eliminated, they can be prevented by following certain sets of procedures called as "Standard Operating Procedures" (SOP). If you are a regulatory professional responsible for process improvement in your organization more ....
Your software system must meet the regulatory requirements and be beneficial to the real world. To this end, the FDA requires your system to be validated. The verification and validation (V&V) has become a critical part of the software development process for a medical device. The Requirements traceability matrix (RTM) is a key piece that establishes the system is fully implemented more ....
Before releasing a medical product, the product should undergo sterility testing. This test is a microbiological test to determine whether the product is sterile to be sold or released. If the product fails the sterility test, it can hold up the product release for months and can cost a lot of money. It is therefore extremely critical to understand the steps to follow when performing a sterility test more ....
Are you responsible for implementing advertising and promotional activities in your organization? Do you hold a key collateral role in reviewing advertising? Are you an official related to the advertising and promotional areas? If yes, understanding the FDA laws and regulations on regulated products governing advertising and promotion is crucial to your professional more ....
Compliance risk management is essential to the successful performance of a regulated firm. It forms the basis for managing all levels within an organization. The compliance risk management business process is a common process for Medical devices, pharmaceutical and combination products. To achieve excellence in risk management, it is crucial for the top management and key personnel more ....
The challenge of getting advertising and promotions right is growing. The bar is high for personnel in the advertising and promotions departments of the Drug and Medical Device Companies. Traditional medical marketing backgrounds and capabilities are necessary but no more enough for the organization's success. They need to acquire the skills to develop safe, effective more ....
If you are a microbiologist or a professional at a site that manufactures drug products and drug substances, you must understand the microorganisms in water systems and how best to monitor and control them. Having a high purity water system alone does not guarantee contamination-free facility processes and products. It is crucial to understand the microorganisms in water and learn how to apply more ....
What are your top concerns about FDA inspection? The first step to address concerns is to gain an understanding of how to prepare for an FDA inspection. This article provides guidance about what to do before, during and after the inspection to ensure proper planning. 'Failing to plan is planning to fail' - By developing an inspection readiness plan, you not only reduce concerns more ....
For medical device manufacturers, gaining access to multiple major markets is important for the success of the company. However, to enter multiple markets, they have to comply with the guidelines, regulations, procedures and deadlines of various regulatory jurisdictions that govern the markets they want to operate. During this process, Companies are subject to multiple audits more ....
The MDSAP program reduces regulatory burdens and saves significant time and money for Medical Device Manufactures. It increases patient safety by reducing risk. Understanding the Audit Process can bolster the confidence in applying MDSAP and help in preparing your organization for the valuable pursuit of certification. Currently, MDSAP is voluntary more ....
'Failing to plan is planning to fail.' This adage applies to Medical Device Manufacturers in several ways. Many Medical Device manufacturers have failed in planning their vendor evaluation and management process well. As a result, they have faced devastating quality issues and received FDA warning letters. The regulators hold the medical device manufacturers more ....
The regulatory bodies hold medical device manufacturers responsible for every step of their supply chain. The increasing complexity in global and outsourced supply requires the manufactures to implement a life-cycle management approach. The surge in Medical device recalls in the U.S in recent years has led FDA to increase its scrutiny of manufacturers' supplier controls more ....
Are you a personnel involved in medical device reporting (MDR) and correction & removal processes? If yes, familiarizing yourself the MDR and recall compliance are critical to your professional development and continued survival of medical device Company you serve. The FDA continues to issue numerous warning letters and enforce serious actions, including criminal and civil penalties more ....
FDA requires Medical device manufacturers to report events that involve medical devices in order to detect and correct problems in a timely manner. Despite the best planning of medical devices, sometimes adverse events occur. These events may include medical device malfunctions, serious injuries, and deaths. Noncompliance may cost may cost millions in fines, product recalls, and litigations more ....
Medical products must be sterilized prior to their use. Radiation sterilization deactivates microorganisms such as bacteria, fungi, viruses, and spores by relying on ionizing radiation, primarily gamma, X-ray or electron radiation. The medical device, biologic products, and pharmaceutical professionals who desire to get a complete understanding of the validation more ....
Many Medical Device Software users face a host of challenges. These include Software failure, malicious remote hacking, and interoperability issues. As the software gets more sophisticated, fixing the software malfunction becomes more difficult. When such malfunctions do occur, it is difficult to decide who is responsible for managing and fixing software problems more ....
Medical Devices that are manufactured for human applications like treatment and diagnosis must be safe and effective. Such devices include instruments, an apparatus, or a material that are used for daily patient care or medical scientific purposes. Manufacturers responsible for developing new devices should take adequate precautionary measures to ensure that the devices don't cause hazards more ....
ISO 13485:2003 certificates are expiring with the Medical Device Single Audit Program (MDSAP) on February 28, 2019. Have you implemented the new ISO 13485:2016 yet? Medical device manufacturers, importers, distributors, and dealers in Europe and in the global markets who want to transition to the new ISO 13485:2016 will benefit from this article. Your implementation time until March 2019 is short more ....
Pharmaceutical companies are increasingly using contract manufacturing organizations (CMO) to reduce overheads and overall costs, and speed up the drug development timelines. While outsourcing provides several advantages, it also presents many challenges. Organizations that outsource do not have direct control over the CMO operations. Most of the CMOs deal more ....
Outsourcing has become a key business strategy. Over the years, the healthcare industry has shown significant progress in capitalizing on it. Contract manufacturing organization (CMO) assist healthcare companies to manage their comprehensive operations on a contract basis including drug development, formulation development, stability studies, drug manufacturing and more. Healthcare companies more ....
Raw materials are the foundation of finished products. Even a small molecule may require about twenty or less raw materials and a large molecule biotechnology product may require as many as sixty raw materials. As such, they must meet your specifications and also the regulatory requirements. In the cGMP environment, a key to ensuring that the raw material meets your expectations more ....
Raw materials are basic to the final product. Raw materials used in the making of a biologic product can impact drug interaction, quality, and patient safety. As the goal of the biologic drug is to treat a patient, raw material quality can influence the efficacy of the drug. The other qualities of a biologic drug including its shelf life can be affected if the raw materials more ....
The FDA requires that the testing of regulated products such as Pharmaceuticals, medical devices, cosmetics, and Dietary supplements must satisfy certain performance criteria. If the test results fail to meet the performance criteria, the FDA does not accept the products. A method validation is performed to determine the reliability of an analytical method more ....
Reliable analytical results help in making informed decisions about the quality and safety of the products in the pharmaceutical industry. Also, such analytical data are essential to support the drug product registrations. Learning how to execute document development, how to demonstrate FDA and EU compliance to auditors and inspectors, how to explain company's strategy more ....
The FDA has increased scrutiny for extractable and leachable associated biotechnology drug products in recent years. Biologics products are particularly sensitive to leachable. Companies are increasingly looking for better ways to conserve the time and resources required for extractable or leachable studies through proper planning. However, prior to planning the extractable more ....
Any new drug development process involves the following steps to ensure that the product is safe and efficacious. The steps include: Discovery and development, Pre-clinical research, Clinical research, FDA review, FDA Post-Market Safety Monitoring. This article sheds light into phase 1 of the 3rd step which is 'first-in-human' clinical trial Directors, managers, supervisors more ....
'The federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across the state lines.' A sponsor who wishes to conduct a clinical trial that involves an investigational new drug (IND), should obtain exemption from FDA to allow the shipping of the investigational drug to clinical investigators in many states more ....
To gain approval for new drugs, Drug companies must ensure that the clinical data they generate is trustworthy. Clinical data management (CDM) is an important phase in clinical research that leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management includes the entry, verification, validation more ....
A large number of quality control related 483s and warning letters in recent years demonstrate that regulated companies are having problems with the implementation of regulations for quality control laboratories. FDA and other agencies have held inspections of QC laboratories in the highest emphasis because the drug products and APIs (Active Pharmaceutical Ingredient) are released more ....
Paper and electronic laboratory documents are a crucial part of your daily operations. It is important to manage them well with a good system. This article is designed to help you gain an understanding of proper documentation and record-keeping for the successful performance. The importance of laboratory documents: Documents provide essential guidelines for the laboratory more ....
Money laundering is rampant globally. 'The estimated amount of money laundered globally in one year is 2 - 5% of global GDP, or $800 billion - $2 trillion in current US dollars.' (UNDOC). The staff of financial institutions, must be aware of their responsibilities in preventing the 'dirty money' entering into the system. They must also understand the Anti-money laundering regulations more ....
A Travel and Expense policy is crucial to an organization for many reasons. It improves the bottom line, keeps occupational fraud at bay, streamlines the booking and reimbursement process, and helps comply with IRS regulations. It takes a lot of resources to process expense receipts, verify if the receipts and expense tally, audit, and reimburse the staff for out-of-pocket expenses more ....
Fraud is rampant everywhere. The total cost of occupational fraud exceeded $7.1 billion according to the 2018 AFCE survey reports. The survey included 2690 cases of occupational fraud in 125 different countries that were reported by Certified Fraud Examiners. This according to AFCE 'does not come close to representing the total amount lost to fraud. The true global cost of fraud is likely more ....
Employees often incur Travel and expenses (T&E) during the course of their employment. Employers can reimburse such expenses on a tax-free basis. However, the reimbursements can become fully taxable if the Employer's T&E Policy is not IRS compliant or if the employees fail to adequately substantiate their business expenses. These standards are popularly known as an accountable plan more ....
There are many advantages of optimizing your Accounts Payable process. It can increase the effectiveness and efficiency of operations, facilitate reliable financial reporting, and ensure compliance with laws and regulations. An optimized account payable can position you for improved liquidity, mitigate potential funding gaps, and yield higher profits. more ....
If you are a manufacturer, importer, or a distributor, of electrical and electronic equipment (EEE) placing products on the UK market, understanding ROHS and REACH compliance is vital. Compliance protects your products from stop shipments and fines. It helps meet the requirements of customers and governments globally. It also minimizes waste, scrap, and rework, enhances more ....
Any manufacturers or importers placing the electrical and electronic equipment (EEE) have a shared responsibility of compliance with ROHS directive and REACH regulations. Also, the distributors including retailers are responsible for compliance. Before understanding how to build a RoHS and REACH compliance program, it is important to know the directive and the regulation more ....
The CMS uses The Hierarchical Condition Category (HCC) risk adjustment model to estimate the predicted cost for Medicare beneficiaries. The HCC assigns each patient a Risk Adjustment Factor (RAF). RAF is a relative measure of the probable costs of care for the individual patient. The reimbursement a Healthcare organization receives for patients enrolled more ....
Nobody wants to be underpaid. No reasonable person will overbill his services. Everyone desires timely payments. So is it with physicians and providers. However, some physicians and providers don’t receive accurate and timely payments for the furnished services. It's because of the physician's failure to bill the correct level of care. The OIG report 2010 found that 42% of claims more ....
Electronic health records (EHRs) are widely used by providers and physician practices. These EHRs are programmed to automatically select E/M codes based on documentation. Although the EHRs are of great value, providers should review guidelines with physicians and coders of the organization to ensure error-free coding and achieve proper reimbursement more ....
If your organization is subject to HIPAA compliance audit, it is important to familiarize yourself with the regulations to ensure adherence. Noncompliance can result in heavy fines, criminal charges and civil action lawsuits should an electronic Protected Health Information (ePHI) breach occur. Whether the violation is deliberate or inadvertent, the Office for Civil Rights of the more ....
If your organization is FDA regulated, it's important to be prepared for the OCR HIPAA Audit by reviewing your HIPAA compliance measures to ensure that all the required policies and procedures have been documented. While reviewing your organization's practices, the Audit will also review how business associates work toward keeping Patient Health Information more ....
The healthcare compliance affects every type of provider from a solo practitioner to the largest global healthcare conglomerate. With soaring medical fraud rates, there is an increase in governmental inquiries, audits and investigations. Enforcement actions against hospitals, doctors and other provider types demonstrates financial penalties, fines, settlements and even more ....
A Healthcare compliance program is a regulatory requirement for various segments of the healthcare industry, such as hospitals, nursing homes, third-party billers, and durable medical equipment suppliers. The compliance officer, the compliance committee, the c-suite and any healthcare compliance professional of healthcare organizations can greatly benefit by understanding more ....
Whether you are an established or an aspiring case manager, learning what you need to succeed in your career will equip you for greater performance. The healthcare landscape is rapidly changing and so is the role of case management in that landscape. In such a rapidly changing healthcare environment, case managers must go through the 3 steps outlined below: more ....
If you are a practitioner in validation and compliance, you must understand and utilize statistical methods for quality engineering whenever possible. Your work provides the basis for future manufacturing and selection of criteria in pharmaceutical process. Documentation of your work is used in regulatory submissions, regulatory audits, change control, and other activities that support more ....
In business, decisions need to be taken based on data. Statistical thinking guides decision making based on the analysis of data. Many companies have a lot of data but don't know to turn their data into useful and actionable information. However, companies that make the best use of their available data achieve a competitive advantage by optimizing their operations and making more ....
Organizations outsource critical functions like technology and security solutions. The benefits of outsourcing are attractive. However, there are also inherent risks involved with outsourced services. Risks associated with vendors who support an organization's technology and or/ security solutions include cyber-attacks, Wi-Fi attacks, DDoS attacks, third-party attacks and more more ....
Almost all organizations need the support of Information technology product and service vendors. During this collaboration process, often the vendors and their vendors may have to access the organization's data. Companies must determine which vendors get what level of access to data and how. All the preceding requires organizations to implement a comprehensive risk management more ....